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JollyRX
Empire Heights A , Shuraa Gold, 9th Floor, Office 412, Business Bay Dubai, AE
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61b4771fc68d1bd7476c6688 VIEKIRAX 12.5/75/50 MG 56 TAB. //cdn.storehippo.com/s/6052eead9e1cf8aa024c48c8/61b476cf4f0b50fb6c47bf65/webp/viekirax.jpg

What is VIEKIRA PAK and how is it used?

VIEKIRA PAK is a prescription medicine used with or without ribavirin to treat adults with genotype 1 chronic (lasting a long time) hepatitis C virus (HCV) infection.

VIEKIRA PAK can be used in people who have compensated cirrhosis.

VIEKIRA PAK is not for people with advanced cirrhosis (decompensated). If you have cirrhosis, talk to your healthcare provider before taking VIEKIRA PAK.

VIEKIRA PAK contains 2 different types of tablets:

  • The pink tablet contains the medicines ombitasvir, paritaprevir and ritonavir
  • The beige tablet contains dasabuvir

It is not known if VIEKIRA PAK is safe and effective in children under 18 years of age.

What are the possible side effects of VIEKIRA PAK?

VIEKIRA PAK can cause serious side effects, including:

See “What is the most important information I should know about VIEKIRA PAK?”

Common side effects of VIEKIRA PAK when used with ribavirin include:

  • tiredness
  • nausea
  • itching
  • skin reactions such as redness or rash
  • sleep problems
  • feeling weak

Common side effects of VIEKIRA PAK when used without ribavirin include:

  • nausea
  • itching
  • sleep problems

These are not all the possible side effects of VIEKIRA PAK. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

DESCRIPTION

VIEKIRA PAK is ombitasvir, paritaprevir, ritonavir fixed dose combination tablets copackaged with dasabuvir tablets.

Ombitasvir, paritaprevir, ritonavir fixed dose combination tablet includes a hepatitis C virus NS5A inhibitor (ombitasvir), a hepatitis C virus NS3/4A protease inhibitor (paritaprevir), and a CYP3A inhibitor (ritonavir) that inhibits CYP3A mediated metabolism of paritaprevir, thereby providing increased plasma concentration of paritaprevir. Dasabuvir is a hepatitis C virus non-nucleoside NS5B palm polymerase inhibitor, which is supplied as separate tablets in the copackage. Both tablets are for oral administration.

Ombitasvir

The chemical name of ombitasvir is Dimethyl ([(2S,5S)-1-(4-tert-butylphenyl) pyrrolidine-2,5- diyl]bis{benzene-4,1-diylcarbamoyl(2S)pyrrolidine-2,1-diyl[(2S)-3-methyl-1-oxobutane-1,2- diyl]})biscarbamate hydrate. The molecular formula is C50H67N7O8•4.5H2O (hydrate) and the molecular weight for the drug substance is 975.20 (hydrate). The drug substance is white to light yellow to light pink powder, and is practically insoluble in aqueous buffers but is soluble in ethanol. Ombitasvir has the following molecular structure:

Ombitasvir - Structural Formula Illustration

Paritaprevir

The chemical name of paritaprevir is (2R,6S,12Z,13aS,14aR,16aS)-N-(cyclopropylsulfonyl)-6-{[(5-methylpyrazin-2-yl)carbonyl]amino}-5,16-dioxo-2-(phenanthridin-6-yloxy)-1,2,3,6,7,8,9,10,11,13a,14,15,16,16a-tetradecahydrocyclopropa[e]pyrrolo[1,2-a][1,4] diazacyclopentadecine-14a(5H)-carboxamide dihydrate. The molecular formula is C40H43N7O7S•2H2O (dihydrate) and the molecular weight for the drug substance is 801.91 (dihydrate).

The drug substance is white to off-white powder with very low water solubility. Paritaprevir has the following molecular structure:

Paritaprevir - Structural Formula Illustration

Ritonavir

The chemical name of ritonavir is [5S-(5R*,8R*,10R*,11R*)]10-Hydroxy-2-methyl-5-(1-methyethyl)-1- [2-(1-methylethyl)-4-thiazolyl]-3,6-dioxo-8,11-bis(phenylmethyl)-2,4,7,12-tetraazatridecan-13-oic acid,5-thiazolylmethyl ester. The molecular formula is C37H48N6O5S2 and the molecular weight for the drug substance is 720.95. The drug substance is white to off white to light tan powder practically insoluble in water and freely soluble in methanol and ethanol. Ritonavir has the following molecular structure:

Ritonavir - Structural Formula Illustration

Ombitasvir, Paritaprevir, Ritonavir Fixed-Dose Combination Tablets

Ombitasvir, paritaprevir, and ritonavir film-coated tablets are co-formulated immediate release tablets. The tablet contains copovidone, K value 28, vitamin E polyethylene glycol succinate, propylene glycol monolaurate Type I, sorbitan monolaurate, colloidal silicon dioxide/colloidal anhydrous silica, sodium stearyl fumarate, polyvinyl alcohol, polyethylene glycol 3350/macrogol 3350, talc, titanium dioxide, and iron oxide red. The strength for the tablet is 12.5 mg ombitasvir, 75 mg paritaprevir, 50 mg ritonavir.

Dasabuvir

The chemical name of dasabuvir is Sodium 3-(3-tert-butyl-4-methoxy-5-{6-[(methylsulfonyl)amino]naphthalene-2-yl}phenyl)-2,6-dioxo-3,6-dihydro-2H-pyrimidin-1-ide hydrate (1:1:1). The molecular formula is C26H26N3O5S•Na•H2O (salt, hydrate) and the molecular weight of the drug substance is 533.57 (salt, hydrate). The drug substance is white to pale yellow to pink powder, slightly soluble in water and very slightly soluble in methanol and isopropyl alcohol. Dasabuvir has the following molecular structure:

Ritonavir - Structural Formula Illustration

Dasabuvir is formulated as a 250 mg film-coated, immediate release tablet containing microcrystalline cellulose (D50-100 um), microcrystalline cellulose (D50-50 um), lactose monohydrate, copovidone, croscarmellose sodium, colloidal silicon dioxide/anhydrous colloidal silica, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350/macrogol 3350, talc, and iron oxide yellow, iron oxide red and iron oxide black. Each tablet contains 270.3 mg dasabuvir sodium monohydrate equivalent to 250 mg dasabuvir.

INDICATIONS

VIEKIRA PAK is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) [see DOSAGE AND ADMINISTRATION and Clinical Studies]:

  • genotype 1b without cirrhosis or with compensated cirrhosis
  • genotype 1a without cirrhosis or with compensated cirrhosis for use in combination with ribavirin.

DOSAGE AND ADMINISTRATION

Testing Prior To The Initiation Of Therapy

  • Test all patients for evidence of current or prior HBV infection by measuring hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc) before initiating HCV treatment with VIEKIRA PAK [see WARNINGS AND PRECAUTIONS].
  • Prior to initiation of VIEKIRA PAK, assess for laboratory and clinical evidence of hepatic decompensation [see WARNINGS AND PRECAUTIONS].

Recommended Dosage In Adults

VIEKIRA PAK is ombitasvir, paritaprevir, ritonavir fixed dose combination tablets copackaged with dasabuvir tablets.

The recommended oral dosage of VIEKIRA PAK is two ombitasvir, paritaprevir, ritonavir tablets once daily (in the morning) and one dasabuvir tablet twice daily (morning and evening). Take VIEKIRA PAK with a meal without regard to fat or calorie content [see CLINICAL PHARMACOLOGY].

HOW SUPPLIED

Dosage Forms And Strengths

VIEKIRA PAK is ombitasvir, paritaprevir, ritonavir fixed dose combination tablets copackaged with dasabuvir tablets.

  • Ombitasvir, paritaprevir, ritonavir 12.5/75/50 mg tablets are pink-colored, film-coated, oblong biconvex shaped, debossed with “AV1” on one side.
  • Dasabuvir 250 mg tablets are beige-colored, film-coated, oval-shaped, debossed with “AV2” on one side. Each tablet contains 270.3 mg dasabuvir sodium monohydrate equivalent to 250 mg dasabuvir.

Storage And Handling

VIEKIRA PAK is dispensed in a monthly carton for a total of 28 days of therapy. Each monthly carton contains four weekly cartons. Each weekly carton contains seven daily dose packs.

Each child resistant daily dose pack contains four tablets: two 12.5/75/50 mg ombitasvir, paritaprevir, ritonavir tablets and two 250 mg dasabuvir tablets, and indicates which tablets need to be taken in the morning and evening. The NDC number is 0074-3093-28.

Ombitasvir, paritaprevir, ritonavir 12.5/75/50 mg tablets are pink-colored, film-coated, oblong biconvex shaped, debossed with “AV1” on one side. Dasabuvir 250 mg tablets are beige-colored, film-coated, oval-shaped, debossed with “AV2” on one side.

Store at or below 30°C (86°F).

SIDE EFFECTS

If VIEKIRA PAK is administered with ribavirin (RBV), refer to the prescribing information for ribavirin for a list of ribavirin-associated adverse reactions.

The following adverse reaction is described below and elsewhere in the labeling:

  • Risk of Hepatic Decompensation and Hepatic Failure in Patients with Cirrhosis [see WARNINGS AND PRECAUTIONS]
  • Increased Risk of ALT Elevations [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of VIEKIRA PAK cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety assessment was based on data from seven clinical trials in more than 2,000 subjects who received VIEKIRA PAK with or without ribavirin for 12 or 24 weeks.

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VIEKIRAX 12.5/75/50 MG 56 TAB.


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Description of product

What is VIEKIRA PAK and how is it used?

VIEKIRA PAK is a prescription medicine used with or without ribavirin to treat adults with genotype 1 chronic (lasting a long time) hepatitis C virus (HCV) infection.

VIEKIRA PAK can be used in people who have compensated cirrhosis.

VIEKIRA PAK is not for people with advanced cirrhosis (decompensated). If you have cirrhosis, talk to your healthcare provider before taking VIEKIRA PAK.

VIEKIRA PAK contains 2 different types of tablets:

  • The pink tablet contains the medicines ombitasvir, paritaprevir and ritonavir
  • The beige tablet contains dasabuvir

It is not known if VIEKIRA PAK is safe and effective in children under 18 years of age.

What are the possible side effects of VIEKIRA PAK?

VIEKIRA PAK can cause serious side effects, including:

See “What is the most important information I should know about VIEKIRA PAK?”

Common side effects of VIEKIRA PAK when used with ribavirin include:

  • tiredness
  • nausea
  • itching
  • skin reactions such as redness or rash
  • sleep problems
  • feeling weak

Common side effects of VIEKIRA PAK when used without ribavirin include:

  • nausea
  • itching
  • sleep problems

These are not all the possible side effects of VIEKIRA PAK. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

DESCRIPTION

VIEKIRA PAK is ombitasvir, paritaprevir, ritonavir fixed dose combination tablets copackaged with dasabuvir tablets.

Ombitasvir, paritaprevir, ritonavir fixed dose combination tablet includes a hepatitis C virus NS5A inhibitor (ombitasvir), a hepatitis C virus NS3/4A protease inhibitor (paritaprevir), and a CYP3A inhibitor (ritonavir) that inhibits CYP3A mediated metabolism of paritaprevir, thereby providing increased plasma concentration of paritaprevir. Dasabuvir is a hepatitis C virus non-nucleoside NS5B palm polymerase inhibitor, which is supplied as separate tablets in the copackage. Both tablets are for oral administration.

Ombitasvir

The chemical name of ombitasvir is Dimethyl ([(2S,5S)-1-(4-tert-butylphenyl) pyrrolidine-2,5- diyl]bis{benzene-4,1-diylcarbamoyl(2S)pyrrolidine-2,1-diyl[(2S)-3-methyl-1-oxobutane-1,2- diyl]})biscarbamate hydrate. The molecular formula is C50H67N7O8•4.5H2O (hydrate) and the molecular weight for the drug substance is 975.20 (hydrate). The drug substance is white to light yellow to light pink powder, and is practically insoluble in aqueous buffers but is soluble in ethanol. Ombitasvir has the following molecular structure:

Ombitasvir - Structural Formula Illustration

Paritaprevir

The chemical name of paritaprevir is (2R,6S,12Z,13aS,14aR,16aS)-N-(cyclopropylsulfonyl)-6-{[(5-methylpyrazin-2-yl)carbonyl]amino}-5,16-dioxo-2-(phenanthridin-6-yloxy)-1,2,3,6,7,8,9,10,11,13a,14,15,16,16a-tetradecahydrocyclopropa[e]pyrrolo[1,2-a][1,4] diazacyclopentadecine-14a(5H)-carboxamide dihydrate. The molecular formula is C40H43N7O7S•2H2O (dihydrate) and the molecular weight for the drug substance is 801.91 (dihydrate).

The drug substance is white to off-white powder with very low water solubility. Paritaprevir has the following molecular structure:

Paritaprevir - Structural Formula Illustration

Ritonavir

The chemical name of ritonavir is [5S-(5R*,8R*,10R*,11R*)]10-Hydroxy-2-methyl-5-(1-methyethyl)-1- [2-(1-methylethyl)-4-thiazolyl]-3,6-dioxo-8,11-bis(phenylmethyl)-2,4,7,12-tetraazatridecan-13-oic acid,5-thiazolylmethyl ester. The molecular formula is C37H48N6O5S2 and the molecular weight for the drug substance is 720.95. The drug substance is white to off white to light tan powder practically insoluble in water and freely soluble in methanol and ethanol. Ritonavir has the following molecular structure:

Ritonavir - Structural Formula Illustration

Ombitasvir, Paritaprevir, Ritonavir Fixed-Dose Combination Tablets

Ombitasvir, paritaprevir, and ritonavir film-coated tablets are co-formulated immediate release tablets. The tablet contains copovidone, K value 28, vitamin E polyethylene glycol succinate, propylene glycol monolaurate Type I, sorbitan monolaurate, colloidal silicon dioxide/colloidal anhydrous silica, sodium stearyl fumarate, polyvinyl alcohol, polyethylene glycol 3350/macrogol 3350, talc, titanium dioxide, and iron oxide red. The strength for the tablet is 12.5 mg ombitasvir, 75 mg paritaprevir, 50 mg ritonavir.

Dasabuvir

The chemical name of dasabuvir is Sodium 3-(3-tert-butyl-4-methoxy-5-{6-[(methylsulfonyl)amino]naphthalene-2-yl}phenyl)-2,6-dioxo-3,6-dihydro-2H-pyrimidin-1-ide hydrate (1:1:1). The molecular formula is C26H26N3O5S•Na•H2O (salt, hydrate) and the molecular weight of the drug substance is 533.57 (salt, hydrate). The drug substance is white to pale yellow to pink powder, slightly soluble in water and very slightly soluble in methanol and isopropyl alcohol. Dasabuvir has the following molecular structure:

Ritonavir - Structural Formula Illustration

Dasabuvir is formulated as a 250 mg film-coated, immediate release tablet containing microcrystalline cellulose (D50-100 um), microcrystalline cellulose (D50-50 um), lactose monohydrate, copovidone, croscarmellose sodium, colloidal silicon dioxide/anhydrous colloidal silica, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350/macrogol 3350, talc, and iron oxide yellow, iron oxide red and iron oxide black. Each tablet contains 270.3 mg dasabuvir sodium monohydrate equivalent to 250 mg dasabuvir.

INDICATIONS

VIEKIRA PAK is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) [see DOSAGE AND ADMINISTRATION and Clinical Studies]:

  • genotype 1b without cirrhosis or with compensated cirrhosis
  • genotype 1a without cirrhosis or with compensated cirrhosis for use in combination with ribavirin.

DOSAGE AND ADMINISTRATION

Testing Prior To The Initiation Of Therapy

  • Test all patients for evidence of current or prior HBV infection by measuring hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc) before initiating HCV treatment with VIEKIRA PAK [see WARNINGS AND PRECAUTIONS].
  • Prior to initiation of VIEKIRA PAK, assess for laboratory and clinical evidence of hepatic decompensation [see WARNINGS AND PRECAUTIONS].

Recommended Dosage In Adults

VIEKIRA PAK is ombitasvir, paritaprevir, ritonavir fixed dose combination tablets copackaged with dasabuvir tablets.

The recommended oral dosage of VIEKIRA PAK is two ombitasvir, paritaprevir, ritonavir tablets once daily (in the morning) and one dasabuvir tablet twice daily (morning and evening). Take VIEKIRA PAK with a meal without regard to fat or calorie content [see CLINICAL PHARMACOLOGY].

HOW SUPPLIED

Dosage Forms And Strengths

VIEKIRA PAK is ombitasvir, paritaprevir, ritonavir fixed dose combination tablets copackaged with dasabuvir tablets.

  • Ombitasvir, paritaprevir, ritonavir 12.5/75/50 mg tablets are pink-colored, film-coated, oblong biconvex shaped, debossed with “AV1” on one side.
  • Dasabuvir 250 mg tablets are beige-colored, film-coated, oval-shaped, debossed with “AV2” on one side. Each tablet contains 270.3 mg dasabuvir sodium monohydrate equivalent to 250 mg dasabuvir.

Storage And Handling

VIEKIRA PAK is dispensed in a monthly carton for a total of 28 days of therapy. Each monthly carton contains four weekly cartons. Each weekly carton contains seven daily dose packs.

Each child resistant daily dose pack contains four tablets: two 12.5/75/50 mg ombitasvir, paritaprevir, ritonavir tablets and two 250 mg dasabuvir tablets, and indicates which tablets need to be taken in the morning and evening. The NDC number is 0074-3093-28.

Ombitasvir, paritaprevir, ritonavir 12.5/75/50 mg tablets are pink-colored, film-coated, oblong biconvex shaped, debossed with “AV1” on one side. Dasabuvir 250 mg tablets are beige-colored, film-coated, oval-shaped, debossed with “AV2” on one side.

Store at or below 30°C (86°F).

SIDE EFFECTS

If VIEKIRA PAK is administered with ribavirin (RBV), refer to the prescribing information for ribavirin for a list of ribavirin-associated adverse reactions.

The following adverse reaction is described below and elsewhere in the labeling:

  • Risk of Hepatic Decompensation and Hepatic Failure in Patients with Cirrhosis [see WARNINGS AND PRECAUTIONS]
  • Increased Risk of ALT Elevations [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of VIEKIRA PAK cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety assessment was based on data from seven clinical trials in more than 2,000 subjects who received VIEKIRA PAK with or without ribavirin for 12 or 24 weeks.

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